Folic Acid, Pyridoxine, and Cyanocobalamin Combination Treatment and Age-Related Macular Degeneration in Women

Abstract

Context Observational epidemiologic studies indicate a direct association between homocysteine concentration in the blood and risk of age-related macular degeneration (AMD), but randomized trial data to examine the effect of homocysteine-lowering in AMD are lacking. Objective To examine incidence of AMD in a trial of folic acid/vitamin B6/vitamin B12. Design Randomized, double-masked, placebo-controlled trial. Participants 5,442 female health professionals aged 40 years or older with preexisting cardiovascular disease (CVD) or 3 or more CVD risk factors. A total of 5,205 of these women did not have a diagnosis of AMD at baseline and were included in this analysis. Intervention Participants were randomly assigned to receive a combination of folic acid (2.5 mg/d), vitamin B6 (50 mg/d), and vitamin B12 (1 mg/d), or placebo. Main Outcome Measures Total AMD, defined as a self-report documented by medical record evidence of an initial diagnosis after randomization, and visually-significant AMD, defined as confirmed incident AMD with visual acuity of 20/30 or worse attributable to this condition. Results After an average of 7.3 years of treatment and follow-up, there were 55 cases of AMD in the folic acid/B6/B12 group and 82 in the placebo group (relative risk [RR], 0.66; 95% confidence interval [CI], 0.47–0.93; p=0.02). For visually-significant AMD, there were 26 cases in the folic acid/B6/B12 group and 44 in the placebo group (RR, 0.59; 95% CI, 0.36–0.95; p=0.03). Conclusions These randomized trial data from a large cohort of women at high risk of CVD indicate that daily supplementation with folic acid/B6/B12 may reduce the risk of AMD.

Peripapillary Retinal Nerve Fibre Layer Thinning Secondary to Nutritional Folic Acid Deficiency

“…31 It is well known that an increased homocysteine level increases age-related macular degeneration and risk of stroke; that is why these risks should be considered when evaluating patients who lack folic acid. 32,33 One weakness of our report is that we did not measure the red blood cell folate level, which is evaluated as a better measure of chronic folate deficiency than serum folate level.…”

Review of nutrient actions on age-related macular degeneration

“…However, no association was found for folate levels [53]. More recently, a randomized trial of 5442 females revealed a decreased risk of AMD in participants who took daily supplements of folic acid (vitamin B 9 ), pyridoxine (vitamin B 6 ), and cyanocobalamin (vitamin B 12 ) [54]. As with the previously discussed vitamin groups, more research is needed prior to drawing any conclusions regarding the efficacy of using B vitamins to prevent or treat AMD.…”

Nutritional Supplement Use and Age-Related Macular Degeneration

“…In the Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), 5,442 female health professionals participated in this randomized, double-masked, placebo controlled trial 132 . Christen et al reported that daily supplementation with folic acid/B 6 /B 12 reduce the risk of AMD in this large cohort of females after an average of 7.3 years of treatment and follow-up.…”